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A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Cognition

Treatments

Drug: donepezil
Drug: Placebo
Drug: AZD1446

Study type

Interventional

Funder types

Industry

Identifiers

NCT01044342
D2285M00021

Details and patient eligibility

About

The purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by electroencephalogram (EEG) measures.

Enrollment

20 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI 18-30
  • Non-smoker for at least 4 weeks

Exclusion criteria

  • Any clinically relevant acute or chronic disease
  • Hypersensitivity to scopolamine
  • History of substance abuse

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 4 patient groups, including a placebo group

A
Experimental group
Description:
Single dose of AZD1446 10 mg
Treatment:
Drug: AZD1446
Drug: AZD1446
B
Experimental group
Description:
Single dose of AZD1446 80 mg
Treatment:
Drug: AZD1446
Drug: AZD1446
C
Active Comparator group
Description:
Single Dose of Donepezil 5 mg
Treatment:
Drug: donepezil
D
Placebo Comparator group
Description:
Single dose of placebo to match AZD1446
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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